Generation of an Artificial Intelligence Algorithm Based on the Analysis of Melanoma Peri-scar Dermatoheliosis, as a Predictive Factor of Response to Anti-PD-1

In the last decade, the advent of immunotherapies with inhibitors of immune checkpoints, such as anti-PD-1 and anti-CTLA-4, has revolutionized the treatment of advanced or metastatic melanoma. However, the clinical benefit remains limited to a subset of patients. Identifying the patients most likely to benefit from these novel therapies (and avoiding unnecessary toxicity in non-responding patients) is therefore critical. Previous studies found a significant link between the high mutational load of a tumor (TMB) and its response to anti-PD-1 monotherapy, regardless of the histological type of cancer. Unfortunately, TMB measurement is expensive, and requires extensive sequencing approaches difficult to implement in clinical practice. I have shown that melanomas known to be secondary to mutagenic ultraviolet rays (UVR) often carry a high TMB. The cumulative UVR damage translates into visible stigmas termed "dermatoheliosis" on patients' skin, easy to recognize with the naked eye of the clinician around the scar of the primary melanoma. My project proposes to establish, for the first time, dermatoheliosis as a novel predictive factor of response to anti-PD-1 immunotherapy, to be used within multidisciplinary tumor boards as a powerful decision-support tool to select the best treatment option. Specifically, I will 1) develop, validate and test in a prospective manner, an artificial intelligence (AI)-based algorithm, to assess features of pericicatricial dermatoheliosis based on a collection of photographs obtained from patients with unresectable locally advanced or metastatic melanoma 2) demonstrate the link between dermatoheliosis, TMB, immune and treatment response by characterizing pericicatricial skin single cell transcriptomics, as well as tumor DNA, RNA and host immunological profiles of the patients. This directly accessible, non-invasive, surrogate marker for TMB will be a game changer in clinical practice and will subsequently be translated to other skin cancers.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Besancon University Hospital, Besançon, Bourgogne-Franche-Comté, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

▪ Adult patients with inoperable stage III or IV melanoma, or inoperable skin carcinoma (squamous cell carcinoma or basal cell carcinoma).

Retrospective cohort: patients who have received curative treatment with anti-PD1, +/- anti-CTLA-4 or anti-LAG-3 for their skin cancer for at least 90 days, with at least 6 months of follow-up, without immunosuppression and whose primary tumour site is not altered by concomitant dermatosis. Adjuvant immunotherapy is tolerated if it was stopped at least 6 months before the start of curative treatment. Interferon is also tolerated if it was stopped at least 6 months before the start of curative treatment. Radiotherapy is tolerated if it did not take place at the site of the primary melanoma scar. For squamous cell carcinomas, prior radiotherapy on the scar is acceptable (it must simply not have been administered during the period of anti-PD-1 treatment in order to be able to reliably assess the response).

Inoperable primary tumours are eligible. Targeted therapy is accepted before the start of curative treatment with immunotherapy.

Chemotherapy is not accepted prior to the initiation of curative treatment with immunotherapy.

▪ Prospective cohort: Patients who have not received immunotherapy for the management of their skin cancer at the start of curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3.

Adjuvant immunotherapy is tolerated if it has been discontinued for at least 6 months prior to the start of curative treatment. Interferon is also tolerated if it has been discontinued for at least 6 months prior to the start of curative treatment. Radiotherapy is tolerated if it has not been administered at the site of the primary cancer scar.

Targeted therapy is accepted before starting curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3.

Chemotherapy is not accepted before the start of curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3.

▪ Patients who have agreed to participate in the research and have signed an image rights authorisation form.

Exclusion criteria

Retrospective cohort: Patients who have received curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3 for skin cancer for less than 90 days
Patients who received adjuvant immunotherapy within 6 months prior to curative treatment
Patients who received chemotherapy prior to curative treatment
Patients whose primary skin cancer site cannot be photographed (e.g. choroidal melanomas, mucosal melanomas, with the exception of vulvar or penile melanomas, etc.).
Patients treated with systemic corticosteroids (dose greater than 10 mg/day) at the start of the immunotherapy in question,
Patients who are immunocompromised (associated blood disorder, human immunodeficiency virus infection, transplant patients, etc.) at the start of immunotherapy,
Patients with iatrogenic peri-scar vitiligo,
Patients who have refused to participate in the research,
Adults protected by law.

Treatment and study plan

Photo

Other

Photography intake

Primary outcomes

Predictive performance of tumor progression score

Time frame: after 6 months

The predictive score for tumor progression at 6 months will be calculated from the photograph of the excision scar of the patient's primary tumor, as well as the clinical characteristics associated with the prognosis: patient age, sex, phototype, anatomical location and Breslow index of the primary tumour, stage of the skin cancer and WHO performance status at the initiation of the treatment, nature of the treatment administered

Study contacts

Contact information is provided by the study sponsor or research team.

Lise BOUSSEMART, PU-PH

CONTACT

[email protected]

+33240083116

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: HELIOPREDICT

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: May 12, 2023
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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